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Reinforced Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref ZLSG104Model S,M,L,XL,XXLRef ZLSG103Ref ZLSG102
Identity
- Trade Name
- REINFORCED SURGICAL GOWNS EUDAMED
- Device Name
- REINFORCED SURGICAL GOWNS EUDAMED
- Model / Reference
- S,M,L,XL,XXL EUDAMEDZLSG104 EUDAMEDZLSG103 EUDAMEDZLSG102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974742162538 EUDAMED06974742162521 EUDAMED06974742162514 EUDAMED
- Basic UDI-DI
- 697474216SSGRTE EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reinforced Surgical Gowns by Farstar Medical Hubei Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697474216SSGRTE | Class I | Active |
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Manufacturer
- Manufacturer
- Farstar Medical Hubei Ltd.
- EUDAMED SRN
- CN-MF-000017294
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 31903819-493e-4cd4-a698-cc775f4c364d 61 fields · synced Aug 4, 2026
- EUDAMED bc581b00-56a3-4403-bfa5-52c8bc088e17 61 fields · synced May 16, 2026
- EUDAMED 00cba8ff-68e9-411e-b352-99ec6ca4a8e9 61 fields · synced May 19, 2026